CertificateofAnalysis
Product Name: Tofacitinib Citrate
CASNo.:540737-29-9
BatchNo.HF161021Quantity3.66kgsMfg. DateOct.21, 2016PackageAs requiredRep. DateOct. 23, 2016Exp. DateOct. 20, 2018ItemsStandardsResultsAppearanceWhite or off-white solid powderWhite solid powderIdentificationBy IRCompliesBy HPLCCompliesSolubilitySlightly soluble in water, very slightly soluble in methanol, hardly insoluble in ethanol, acetone and acetonitrileCompliesSpecific Rotation+9.0°~ +13.0°(0.6g/100ml in DMSO)+10.0°Loss on Drying≤0.50%0.25%HeavyMetal≤10ppmCompliesResidue on Ignition≤0.20%0.10%Enantiomer(SS) ≤0.1%NDCitrate36.2% ~ 40.0% (on dried basis)38.3%Residual SolventsPetroleum ether: ≤3000ppmNDEthanol: ≤5000ppmNDEthyl ether: ≤5000ppmNDAcetone: ≤5000ppmNDn-Butyl alcohol: ≤5000ppmNDDichloromethane: ≤600ppmNDRelatedSubstances(RS+SR): ≤0.10%NDAny single impurity: ≤0.10%0.05%Total Impurities: ≤0.30%0.07%Assay
(HPLC basis on drying)99.0%~101.0%99.85%Reference StandardIn-house StandardConclusionThe productcompliedtoIn-housestandard.StoragePreserve in tight,light-resistant containers in a cool place